Abstract

OVERVIEW OF DRUG REGULATORY AFFAIRS AND REGULATORY PROFESSION

Rajesh B. Jadhav*, Shankar S. Khandare, Gajanan D. Mogal, Mahesh B. Bhagure and Radhesham M. Jadhav

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Abstract

A regulatory affair is a slightly new profession which has developed from the desire of governments to defend public health. The areas where government controlling the safety and efficacy of products are pharmaceuticals, medical device, veterinary medicines, pesticides, agrochemicals, cosmetics and complementary medicines. The companies responsible for the finding, testing, manufacture and marketing of these products also want to ensure that they supply products that are safe and make a worthwhile contribution to public health and welfare. armaceutical drug regulatory affairs govern registration parameters of pharmaceutical products. It has a comprehensive band covering all aspects of certification and marketing in legalized form. The pharmaceutical industry is highly regulated industries in our country. Regulatory affairs professionals are need of present market scenario to cater to link pharmaceutical industries and worldwide regulatory agencies. Regula tory Affairs (RA), is a profession within synchronized various industries, such as pharmaceuticals, medical devices and biotechnological industries. Regulatory Affairs also has a very specific meaning within the pharmaceutical industries.

Keywords: Regulatory Affairs professionals, Regulatory agencies.